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临床试验/CTRI/2024/11/076776
CTRI/2024/11/076776尚未招募不适用

A study on Efficacy of Aabzan followed by local application of Marham e Maazu in early stages of Bawasir [Hemorrhoids]

Govt Nizamia Tibbi College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction in rectal bleeding, rectal pain, rectal itching, mass per rectum , discomfort during defecation.

研究概览

简要总结

Title of topic

A study on “ EFFICACY OF SITZ BATH FOLLOWED BY

APPLICATION****OF MARHAM E MAAZU IN EARLY STAGES OF

HEMORRHOIDS” in patients attending OPD of tahaffuzi wa samaji tib at Govt Nizamia  General Hospital, Charminar ,Hyderabad

Brief resume of intended work

NEED OF THE STUDY

 Hemorrhoids also called piles are dilated plexus of superior hemorrhoidal veins within the anal canal in subepithelial region. [1][2]

It is one of the most common proctologic conditions in adults.[27]

Although, hemorrhoids are a prevalent anorectal disease with greater socio-economic impact on quality of life of the patients, the epidemiological data is very limited as many patients do not reveal it or avoid seeking medical advice. According to National Institute of Health, the prevalence rate of hemorrhoid is 4.4 %, and approximately 50–86% individuals suffer from hemorrhoids globally. In India, hemorrhoid is reported to be 30–40% in the target population [31] almost 40 million people are reported to have hemorrhoids and one million new cases are reported annually at rate of 47 per 1000 people**.[33]**

It is not selective for any age or sex[1][5].

According to various unani and modern literature, sitz bath and local application of ointment having antihemorrhoidal properties are beneficial as a means of conservative treatment. **[1][2][4][5][9][14][17]**Shab e Yamani and maazu having strong astringent, hemostatic, antiseptic and wound healing properties are recommended for this purpose. [8][14][16][17][22][23][24][28]

This study aims at evaluating the efficacy of Marham maazu and sitz bath containing Shab e Yamani, for their anti-hemorrhoidal properties, and to prevent further complication of hemorrhoids.

In the view of above facts, I would like to conduct a study on evaluating – “EFFICACY OF SITZ BATH  FOLLOWED BY APPLICATION OF MARHAM E MAAZU IN EARLY STAGES OF HEMORRHOIDS” in patients attending OPD of tahaffuzi wa samaji tib at Govt Nizamia General Hospital, Charminar, Hyderabad.

MANAGEMENT:Allopathy management includes conservative /non-operational and operational measures.[1] Conservative methods include increasing fiber supplements, fluid intake, bulk purgatives like ispagol, avoid straining, bowel regulations, sitz bath, applying topical ointments to reduce pain edema and itching.

Antibiotics laxatives and anti-inflammatory drugs are also beneficial.[1][2][4]

Para surgical procedures like sclerotherapy, banding, cryotherapy, etc. are used.[1]

Operative procedure like hemorrhoidectomy is recommended for grade 3 and 4 hemorrhoids.[2]

 Unani principal of treatment includes pharmacotherapy, Regimental therapy, diet therapy and surgery. [33] Usool e ilaj -

â–ª        Real cause should be identified and eliminated [8]

â–ª         Tanqiya e mawad (evacuation), talayyin (laxative), taskeen e dard (analgesic), habis ud dam(hemostatic), indemal and tahleel e warm (healing and resolution of swelling. [19]

Pharmacotherapy- Various drugs having antihemorrhoidal properties like muqil,raswat, habb e bawaseer etc. Local application of medicine.[19]

Regimental therapy – Fasd, leech therapy, hijama, aabzan.[17][20]

Diet therapy- avoid food that produces melancholic blood, avoids hot spicy food and meat. Diet should contain soft and easily digestible food.[25]

Surgery- unani physicians described 3 types of surgery i.e., Khazam, Shad, Qata.[10]

DIFFERNTIAL DIAGNOSIS:[1]§  Fissure in Ano

§  Fistula in Ano

§  Rectal prolapse

§  Perianal warts

COMPLICATIONS:[2][3]§  Chronic anemia

§  Thrombosis and Strangulation

§  Fibrosis and Ulceration

§  Gangrene and Portal pyemia

  ABZAN [SITZ BATH]

Among the various treatments, abzan is a simple, economic, safe , noninvasive and effective external regimen for various diseases. [34]

It is type of bath in which the lower part of the body especially buttocks and hips are immersed into plain or medicated water. [21][35]

Various unani literature suggest using astringent drugs like shab e yamani [14] dissolved in water (aab e qaabiza) for sitz bath in hemorrhoids.[9][14][17][25][26]

Shab e yamani ( aluminium hydroxide) is a mineral drug having mizaj garam and khushk. Its main properties are Qabiz, Habis ud dam, Musakkin, Mujaffif

Maazu (quercus infectoria) is  sard and khushk in mizaj . Its properties are Qabiz, Mujaffif,Habis ud dam and Dafe taffun. It  contains tannic acid and gallic acid, which makes it a potent astringent, hemostatic and antimicrobial agent, that benefits patients with hemorrhoids.[22][23]

6.3

AIMS AND OBJECTIVES OF THE STUDY:

§  This study aims at evaluating the efficacy of sitz bath and application of Marham e maazu in early stages of hemorrhoids.

§  The objective of this study is to create awareness regarding prevention and management of hemorrhoids and improving the well-being and quality of life of patients having hemorrhoids.

|7

MATERIALS AND METHODS

7.1

SOURCEOFDATA –

Patients attending OPD of tahaffuzi wa samaji tib at government Nizamia general hospital, Charminar Hyderabad.

 INCLUSION CRITERIA:

Female patients having uncomplicated hemorrhoids, of age 18-45 years.

External, interno external and  internal hemorrhoids [grade 1 and 2]

 EXCLUSION CRITERIA:

Patients who are not giving informed consent.

Pateints below 18 or above 45. Male patients.

3rd and 4th degree hemorrhoids, Pregnancy , DM or any other rectal disease .

 PARAMETERS FOR STUDY :

§  SUBJECTIVE****PARAMETRS-

Patients complaining of rectal bleeding, rectal pain, rectal itching, mass per rectum , discomfort during defecation.

§  OBJECTIVE****PARAMETERS-

The diagnosis is based on history taking and clinical examination.

 STUDY DESIGN: An experimental - Single arm clinical study

 SAMPLE SIZE: minimum 30

 DURATION OF STUDY: 9 months

 PROCEDURE OF STUDY:

This study will be conducted on 30 subjects meeting the inclusion criteria.

The subjects will be screened for pain intensity, defecation discomfort, anal itching, per rectal bleeding, change in size of external hemorrhoids using suitable scales. Subjects will be given shab e yamani to be used in sitz bath and marham e maazu for local application, twice daily.

Treatment will be given for 2 weeks and follow up will be done on 7th, 14th day and post treatment follow up will be done on 21st day wherein subjects will be enquired for changes in their symptoms and will be clinically assessed.

The purpose of not using a control group or placebo is that the symptoms of hemorrhoids may further get complicated.

 METHOD OF PREPATATION:

MARHAM E MAAZU : 50 g of finely powdered maazu is to be mixed with 500g of Mom-Safed. It is then ground in mortar and pestle to render into an ointment and stored in glass container. [36]

     SUFOOF E SHAB E YAMANI :   Shab e yamani is roasted in iron pan at moderate heat. After it melts and dries down it is ground in mortar and pestle to achieve fine powder.[28]

 For the purpose of sitz bath , 20g of Shab e yamani is to be dissolved into 2L of lukewarm water in a tub and sit into it for 10-15 minutes twice daily, followed by local application of Marham e Maazu in sufficient quantity .

EVALUATION: Data will be analyzed statistically.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Female patients having uncomplicated hemorrhoids, of age 18-45 years.
  • External, interno external and internal hemorrhoids [grade 1 and 2].

排除标准

  • Patients who are not giving informed consent.
  • Pateints below 18 or above
  • Male patients.
  • 3rd and 4th degree hemorrhoids, Pregnancy , DM or any other rectal disease .

结局指标

主要结局

Reduction in rectal bleeding, rectal pain, rectal itching, mass per rectum , discomfort during defecation.

时间窗: On Day 7,14 and 21

次要结局

  • TO resolve hemorrhoids and improve the well-being and quality of life of patients having hemorrhoids.(Day 21)

研究者

发起方
Govt Nizamia Tibbi College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Hafsa

Govt Nizamia Tibbi College and General Hospital

研究点 (1)

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